A Milestone for America’s Patent System

USPTO Director Iancu and Secretary of Commerce Wilbur Ross sign proclamation celebrating 10 millionth patent

“Innovation has been the life blood of this country since its founding,” said Secretary of Commerce Wilbur Ross earlier this week in a press release announcing the 10 millionth patent issued by the United States Patent and Trademark Office (USPTO).

Strong, reliable and enforceable patent laws are the drivers of the biotechnology innovation ecosystem. Without these strong patent rights, the financing to take revolutionary biotechnology discoveries from the lab to the patient, farmer, or consumer would be unavailable. The weakening of these patent rights threatens new investment in the innovation sector of our economy and, with it, the jobs and industries of the future.

Toady in The Hill, BIO’s President and CEO Jim Greenwood addressed our industry’s concerns regarding the deficiencies within the USPTO that have weakened the our patent system that have led to the U.S. Chamber of Commerce to rank our patent system as only 12th in the world, behind nations like Singapore, France, and South Korea.

Read the full Op-ed here.

How to protect your medtech startup’s innovations

Building a strategic patent portfolio is crucial to success for a medtech startup. 

David J. Dykeman, Greenberg Traurig

[Image from Unsplash]

When it comes to starting and building a medical device company, a strong patent strategy tied to business goals can be the driving force behind venture capital investment, strategic collaborations, and mergers and acquisitions.

In order to safeguard its intellectual property (IP), every medtech startup should consider these five tips for protecting and leveraging its innovations.

1. File early and file often

Fundamental to a strong patent portfolio is establishing solid patent protection for a company’s core technology. First, one or a series of patent applications should be filed providing the broadest possible patent protection covering the core technology. As the core technology evolves, incremental improvements and varying applications should be patented to form a “picket fence” of protection around the core technology.

Medtech startups should file patent applications as early and as often as their budget permits. This has been particularly true since the passage of the America Invents Act in 2011, which brought the United States into conformance with the rest of the world as a first-to-file country. Thus, a key is to file patent applications before any public disclosure that could limit patent coverage. To ensure both U.S. and international patent coverage, a patent application should be filed before the invention is first published, disclosed, used or offered for sale. Savvy companies file patent applications early and often.

Get the full story on our sister site Medical Design & Outsourcing. 

The post How to protect your medtech startup’s innovations appeared first on MassDevice.

Double Jeopardy at the PTO Threatens Healthcare Innovation

There has been no shortage of commentary related to the efforts of Allergan to shield itself from the un-American threat of double jeopardy they have repeatedly faced through gamesmanship of the PTO’s Inter Partes Review (IPR) process.

An op-ed by Allergan CEO Brent Saunders today in The Wall Street Journal demonstrates the unconventional steps the company has taken to protect itself from the flaws of IPR that are being “exploited by generic manufacturers and a new breed of reverse trolls.”

Generic pharmaceutical manufacturers, who already have full opportunities to challenge innovator patents in federal court, are using these flaws within IPR to initiate duplicative patent reviews until a sympathetic panel of PTO Administrative Patent Judges renders a decision to invalidate. In the process, they – not Allergan – are undermining the carefully balanced, Congressionally-mandated system that has successfully spurred both innovation and generic drug entry for decades.

IPR undermines the long-established, bi-partisan Hatch-Waxman framework that allows for legitimate patent questions to be litigated in the open in federal court.

To remedy the abuses of IPR, BIO has been calling on Congress for several years to harmonize the legal standards used in IPR and in the federal courts, and provide assurance that patent owners will be free of repeated threats to their intellectual property following a court ruling.

BIO Fall IPCC Meeting: Special Offer for First Time In-House Attendees!

Are you a patent practitioner at a biotech company?

Is your in-house IP group small, or are you perhaps the only “IP person” in your company?

Would you like more opportunities to connect with similarly-situated in-house colleagues, get updates and analysis on patent law developments, share best practices, and participate in policy discussions that affect our industry?

Have you never attended the BIO IP Counsels Committee Conference, but always wanted to?

BIO wants you, and can make it easier to attend.

BIO will waive registration and reimburse $500 in hotel and airline for up to 10 biotech in-house IP counsel first-time attendees. Recipients must have never attended a BIO IPCC Conference before.

The BIO IPCC Conference is organized biannually by the IP Counsels Committee of the Biotechnology Innovation Organization. It is organized by in-house practitioners for in-house practitioners, and over the past decade has become the premiere event for corporate biotech patent counsels and agents, providing valuable opportunities for education, practice pointers, policy discussions, and for meeting similarly-situated colleagues in the industry. Registration policies and programming are designed to ensure that the event first and foremost benefits the in-house community.

Our fall conference will take place November 13-15 in Annapolis, Maryland.

We are continually seeking out ways to enhance its value to our core audience, especially practitioners at smaller companies whose budgets are tight and responsibilities are spread.

Please contact adonohue@bio.org if you believe you qualify.

Registration for BIO’s Fall IP Counsels Committee Conference is NOW OPEN!

Ah, Autumn. A time for pumpkin spice lattes, cozy sweaters, soup, and updates in the biotech patent space.

That’s right, registration for BIO’s Fall IP Counsels Committee Conference is NOW OPEN! Our Fall meeting will take place November 13-15 in Annapolis, Maryland.

Photo Credit to visitannapolis.org

BIO’s IP Counsels Committee Conference is THE place to get the most relevant information and updates on the latest issues in the biotech IP sector. Organized by in-house practitioners, it is the premiere event for corporate biotech patent counsels. We provide opportunities for education, policy discussions, networking, and offer the most up to date information in the field.

Our agenda, details for registration, and other info can be found here. 

Now grab your sailor suits and come join us!

Group of Inventors Burn Their Patents in Protest

As reported last week by IP Watchdog, the United States Patent and Trademark Office (PTO) refused to approve a permit requested by US Inventor for booth or table space within the Agency’s office building  in Alexandra, VA. The group’s objective was to  protest and raise awareness of the ongoing high rates of patent invalidation resulting from decisions made by the Patent Trial and Appeal Board (PTAB).

Despite two denied appeals, US Inventor, a nonprofit organization devoted to improving the U.S. patent system, was undeterred. They opted to set up on the sidewalk outside the PTO. Some of the protestors went so far as to burn their actual patents, citing PTO policies had rendered them worthless.

The PTO’s interim director Joe Matal came out to speak with and listen to members of the group as they expressed their concerns with the PTAB.

Patents burn at US Inventor PTAB protest at the USPTO, Friday, August 11, 2017. Photo taken by @TheRealMattDowd.

The unintended consequences of the PTAB’s administrative patent challenge system known as Inter Partes Review, or IPR, have caused much concern among innovative, intellectual property-reliant companies that are helping to drive this nation’s economic growth. Rather than being a cheaper substitute for expensive district court litigation, these proceedings have produced more litigation, not less, and have perpetuated disputes rather than resolving them sooner.

BIO stands ready to work with Congress and the PTO on efforts to reform the patent system, to ensure better support for inventors, investors, and the people waiting for new biotech innovations treatments to improve their lives and their environment.

Weak Patent Law Endangers Healthcare Innovation

Last week The Wall Street Journal published a fascinating expose that pulled back the curtain on some of the self-serving and well-financed efforts of big high-tech companies (in this case Google) to  influence academic scholarship, and ultimately public policy, in their favor. Such strategies have long been used to undermine the U.S. patent system. As part of their ongoing campaign to weaken existing patent protections, big high tech interest groups have funded troves of exaggerated studies on the pervasiveness of “bad patents” and their abuse by “patent trolls” and “rogue judges.” They do this while ignoring the critical and historic importance of strong and predictable patent rights to economic growth and innovation outside of their particular sector of the economy.

Strong patents are the lifeblood of America’s innovation economy including the biotechnology industry. They are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines, alternative energy sources, and insect and drought resistant crops – capital that has now begun to flow to other countries with stronger patent protections like the European Union and China.   In a recent review of global patent protections, the U.S. Chamber of Commerce reported that the United States dropped from its #1 position to #10, tying with Hungary and falling behind most EU nations, Japan, and Singapore. Read the full report here.

It can take a decade or more of privately funded research and development before a biotech company can bring its product to market.  Only one in ten candidate drugs that make it as far as clinical trials will actually get licensed.  Despite the risks of biotech investment, the industry attracts billions of dollars in new investments each year based on the promise of its innovative and patented discoveries, which will only be translated into actual commercial products providing a return on investment after years, sometimes decades, of capital-intensive investment and research efforts.

Without strong and predictable protections for validly patented innovations, investors will shy away from investing in biotech innovation, degrading the ability to provide solutions to the most pressing medical, agricultural, industrial, and environmental challenges facing our nation and the world.  A short-sighted approach to patent reform will undermine the promise of these initiatives.

Biotechnology is one of the fields where the U.S. remains an undisputed world leader – both in terms of conceptualizing new products and bringing them to market.  Our Congress should be working to preserve and nurture the sectors where the U.S. remains head and shoulders above the rest of the world, where continued advancements hold the greatest societal and economic promise.

Make no mistake: the impact of weakening patent protection would be severe, and the aftershock could be devastating.

Licensing of Academic Patents Has Contributed Up to $1.3 Trillion to US Economy

The licensing of university research has made a significant contribution to US gross domestic product (GDP), industry gross output, and jobs over the last two decades, according to an independent study commissioned by the Biotechnology Innovation Organization (BIO) and the Association of University Technology Managers (AUTM).

The report, “The Economic Contribution of University/Nonprofit Inventions in the United States: 1996- 2015,” documents the sizable return that US taxpayers receive on their investment in federally-funded research. It shows that, during a 20-year period, academic patents and the subsequent licensing to industry bolstered US industry gross output by up to $1.33 trillion, US GDP by up to $591 billion, and supported up to 4,272,000 person years of employment.

“Thanks to the enduring effectiveness of the Bayh-Dole Act, American research universities, along with industry partners, are turning federally-funded basic research into new and valuable products that save and improve lives. The commercialization of university-based research to create new companies and good, high-paying jobs is a key driver of America’s innovation economy,” said BIO President & CEO Jim Greenwood. “This updated study demonstrates that fact.”

DOWNLOAD BIO’S POLICY BRIEF

 

The study, which was conducted by technology transfer experts and former senior economic consultants, is based on data gathered by the Association of University Technology Managers (AUTM) in its annual Licensing Activity Survey. The most recent 2015 survey showed:

  • 1,012 startup companies were formed, averaging 2.75 new companies created every day of the year– up 11.3% from FY 14;
  • 879 new products based on academic inventions were introduced to the marketplace, averaging 2.4 new products introduced every day of the year;
  • Products based on academic patent licenses generated more than $28.7 billion in net product sales; and
  • 7,942 new licenses and options were executed, up 15% from FY 14. More than 70% of academic patent licenses go to small companies.

 

DOWNLOAD THE REPORT

 

BIO Reacts to Supreme Court opinion in Impression Products, Inc. v. Lexmark International, Inc.

On Tuesday, May 30, 2017, the U.S. Supreme Court issued an opinion in  Impression Products, Inc. v. Lexmark International, Inc.

As mentioned in our previous post on this case, the issue before the court was whether or not 1) international sales exhausted patent rights, and 2) if conditional restrictions on the sale of the patent by the patentee exhausted patent rights.

BIO and Croplife International submitted an amicus brief supporting Lexmark International, Inc. in February.

In a 7-1 ruling authored by Chief Justice Roberts, the Court determined that Lexmark had exhausted its patents rights, and could not sue Impression Products for patent infringement with respect to its toner cartridges sold abroad, “because an authorized sale outside the United States, just as one within the United States, exhausts all rights under the Patent Act.”

Justice Ginsburg filed an opinion concurring in part and dissenting in part. Justice Gorsuch took no part in the consideration or decision of the case.

In a post for IP Watchdog, Melissa Brand, BIO’s Associate Counsel and Director, Intellectual Property Policy provided this reaction:

“The Court’s decision will change decades of established commercial practice essential to the U.S. economy.  The Court provided no analysis of whether such sweeping changes are necessary or even beneficial.  Instead, relying on theories of property rights articulated in the 17th Century—a time at which our country was burning people for witchcraft—and a superficial similarity to copyright law, the Court upends established practices, opening the floodgates of grey marketed products to the detriment of consumers in less affluent markets.

With respect to the domestic component, the Court’s decision greatly reduces the incentive for patentees to utilize conditional sales.  This penalizes manufacturers who sell products at preferential prices to special users who could not otherwise afford the product.  For example, manufacturers will have to rethink whether sales for “research use only” to universities at lower cost will continue to be commercially viable.  This could make it more difficult for the end products of such research endeavors to be made available to the public.

The consequences of the Court’s ruling on international exhaustion run counter to decades of U.S. trade negotiations and will have countless unintended and unforeseen consequences.  By extending U.S. patent law to foreign transactions that have nothing to do with the United States, the Court has called into question thousands of existing contracts between patentees and foreign distributors, many of which will now need to be renegotiated.  Further, because regional pricing will now be virtually eliminated, consumers in less affluent markets will be disadvantaged.  This will inevitably lead to an increase in grey marketed goods in the U.S.  FDA regulations and emphasis on drug safety will currently mitigate the potential harm in the pharmaceutical sector, but other industries with less regulation will be immediately impacted.  And it should be noted that, despite the Court’s suggestion to the contrary, this case itself illustrates that contract law will not be an effective alternative: Lexmark was not in privity with Impression Products, and therefore Lexmark could not have sued Impression Products for breach of contract.  Lexmark’s recourse would have been to sue the individual consumers who entered into the Return Program contracts with Lexmark.  Not only would suing individual consumers be unrealistic and expensive, but the remedies available to Lexmark and the ability of the individual consumers to satisfy judgments against them are unclear.”

In a press release, BIO CEO Jim Greenwood issued the following statement:

“BIO is concerned that today’s U.S. Supreme Court ruling in the case of Impression Products  v. Lexmark International could make it more difficult for patients across the world to gain access to critical therapies. The biotechnology industry is overwhelmingly comprised of small companies that rely on the stability and dependability of the patent system to bring innovative technologies to market. We fear this ruling will undermine that stability. The decision systematically undercuts innovative companies willing to sell their products at discounted prices for special uses, such as furthering scientific research and helping underserved populations. By extending the reach of U.S. patent law to foreign transactions that have nothing to do with domestic markets, the Court’s decision creates counterproductive uncertainty for U.S. innovators and their customers.

“BIO will work with our member companies to help them understand and comply with this ruling and adjust their intellectual property strategies accordingly.”

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , , , , ,

BIO Chimes In: TC Heartland LLC v. Kraft Food Brands Group LLC (Supreme Court)

This is part two of a three part series on BIO’s recently submitted amicus briefs in cases before the Supreme Court as well as the U.S. Court of Appeals for the Federal Circuit.

Spring kicked off yesterday, and with it was the beginning of the confirmation process for U.S. Supreme Court nominee Judge Neil M. Gorsuch. Empty seat or not, SCOTUS has a full plate of decisions to reach this term, patent cases among them.

We’ve already talked about BIO’s position on Impression Products v. Lexmark International (oral arguments begin today), so let’s take a look at another important patent case headed to the Supreme Court next week.

At issue in this case is the determination of venue for patentees and the interpretation of Congress’s venue statute. The court is being asked “whether 28 U.S.C. § 1400(b) is the sole and exclusive provision governing venue in patent infringement actions and is not to be supplemented by 28 U.S.C. § 1391(c).”

28 U.S.C. § 1400(b) limits the venue of patent cases to 1) the judicial district where he defendant resides, or 2) where the defendant has committed acts of infringement and has a regular and established place of business.

28 U.S.C. § 1391(c) broadens the definition of residence for venue to be any judicial district where the defendant is subject to the court’s personal jurisdiction. Since patent defendants are generally subject to nationwide personal jurisdiction, venue would be in any jurisdiction.

Given the broad interpretation of 28 U.S.C. § 1391(c), there has been a significant concentration of patent-infringement suits in the Eastern District of Texas, where more than 40% of patent cases are litigated.

BIO and the Association of University Technology Managers (AUTM) submitted an amicus brief supporting Kraft Food Group (the respondent).

In the brief, BIO argues that while it is not good for the patent system to have a concentration of patent cases come up through a single district, “attempting to resolve [these] issues through this case would do significantly more harm than good.”

If the Supreme Court decides in favor of TC Heartland, the venue regime that prevailed prior to 1988 would return, severely inconveniencing patent owners (particularly small businesses) and increase the amount of patent litigation, “forcing patent holders to brin related claims in multiple separate actions, and would skew litigation in favor of accused infringers.”

BIO’s brief further argues that Congressional reform efforts have “recognized the importance of including venue options tied to locations where the patent owner is or was engaged in activities related to the patent.”

BIO and AUTM argue that reform efforts to combat issues with patent venue should be left to Congress, “rather than legislating an obsolete approach to venue that Congress has not endorsed.”

Oral arguments in this case will take place next Monday, March 27, 2017.

Filed under: Patently BIOtech, Public Policy, , , , , , , , , , , , ,