Pharmaceutical/Medical Devices

As scientific and technological development in the medical, pharmaceutical and healthcare fields continues its explosive growth, Oblon Spivak is at the forefront of helping companies identify, protect, license and enforce intellectual property in these important areas. In the pharmaceutical industry alone, billions of dollars are invested in research and development with few drugs actually surviving clinical trials, regulatory clearances and product launch. With such a great investment, companies need skilled attorneys to protect their innovations.

Our clients include both domestic and foreign companies, including major Asian and European companies developing medicines, medical devices, procedures and treatments. We pride ourselves on our longstanding relationships with our clients, many of whom we have represented for more than 40 years. We have the resources and experience to formulate and execute global patent protection strategies for our clients, regularly appearing on their behalf in the United States Patent and Trademark Office (USPTO), before the International Trade Commission (ITC), and courts throughout the United States.

FDA Expertise

In addition to biotechnology and pharmaceutical patent protection, we have specific expertise analyzing the impact of the U.S. Food and Drug Administration’s (FDA) regulations and working within the regulatory framework to identify opportunities, address challenges and provide the broadest patent protection possible for our clients’ intellectual property. We regularly advise clients on lifecycle management (LCM) and patent portfolio enhancement, often handling patent term extensions, exclusivity protection, design-arounds, abbreviated new drug (ANDA) litigation, and other infringement challenges.

Skilled Team of Professionals

Oblon Spivak’s success begins with a distinguished professional staff that includes attorneys with a high level of scientific and technical training in the areas of chemistry, biology, biotechnology, biomedical engineering, medicine, and the electrical and mechanical arts, all of which can play a significant role in pharmaceutical and medical innovations. Many of our lawyers are Ph.D.s whose graduate research directly involved biotechnology. Team members include litigators, attorneys with industry experience and former Patent Examiners with the USPTO.

Strategic Location

In addition to our sophisticated technical backgrounds, our Alexandria, Virginia location-adjacent to the USPTO-enables us to regularly meet face-to-face with USPTO Patent Examiners, enhancing our ability to obtain protection for our clients' inventions while keeping cost to a minimum. Our close working relationship with the USPTO is an important factor contributing to our record of success in obtaining patent protection for our clients.

Comprehensive Intellectual Property Protection

Fully safeguarding inventions sometimes calls for measures beyond patents. We have confronted virtually every type of intellectual property issue in the pharmaceutical and medical device fields and handle all aspects of safeguarding our clients’ innovations, including:

  • Developing and implementing patent prosecution strategies
  • Preparing and negotiating licensing and co-development agreements
  • Providing due diligence and risk assessments for mergers and acquisitions and other business transactions
  • Counseling on antitrust, exclusivity and competition issues
  • Advising on potential litigation strategies, and asserting and defending patents in court
  • Advising on product lifecycle management
  • Representing clients in complex Hatch-Waxman litigation
  • Working collaboratively with our Litigation, Post Grant and Patent Interferences practice groups to fully protect our clients’ innovations
  • Obtaining FDA exclusivities for client products
  • Addressing generic competition

We are experienced with branded products, as well as representation of generic product developers and manufacturers, product launches, the protection of biosimilars, and strategic use of citizens’ petitions to forestall competition.

Forward-Thinking Counsel

As biotechnology development continues to outpace the law, courts are constantly reviewing and revising earlier opinions on patentability, infringement, and issues of public policy. We help clients protect themselves against these legal uncertainties through strategies that build on other legal safeguards, such as trade secret protection and contract protection. By helping our clients incorporate these and other non-patent protection schemes into their portfolios, we assist them in ensuring that they achieve superior commercial success.

Publications

Sunday, January 2, 2011
Friday, July 22, 2011

On July 6, the New Jersey District Court filed an opinion denying the injunctive relief sought by Nostrum Pharmaceuticals LLC regarding the FDA’s decisions on the statutory exclusivity period for Nostrum’s ANDA on...

Monday, July 11, 2011

In Nycomed v. Tolmar, a federal magistrate judge of the District of New Jersey recently held that Paragraph IV notice letters are non-confidential, public disclosures.[1] 

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Wednesday, June 29, 2011

This entry updates the original entry regarding this case posted on January 12, 2011.  The Supreme Court granted certiorari with respect to the Federal Circuit’s decision in ...

Tuesday, June 28, 2011

On May 25th, the Federal Circuit granted an immediate and temporary stay of an injunction against Mylan Pharmaceuticals Inc. and Mylan Inc. (Mylan) in their proceedings with Eurand, Inc...

Friday, June 17, 2011

On June 7, 2011, the Federal Circuit issued its decision in Boston Scientific Corp. v. Johnson & Johnson, Inc.  The Federal Circuit affirmed the district court’s grant of...

Tuesday, April 26, 2011

The U.S. District Court for the District of Columbia will hold a hearing on motions for preliminary injunction and for dismissal in Mylan v. FDA on Thursday, April 28. Plaintiffs Mylan and Matrix brought this suit against the FDA to try to force the agency to enforce its ...

Thursday, April 21, 2011

Pharmaceutical Technologies (“PharmaTech”) filed a false marking complaint under 35 U.S.C. 292 against Eisai on Tuesday, April 5 in the U.S. District Court for the District of Arizona. Notably, the complaint cites the Orange...

Friday, April 08, 2011

The Federal Circuit heard oral argument in Association of Molecular Pathology v. USPTO on Monday, April 4. The case comes to the Federal Circuit on appeal from the U.S. District Court for the Southern District of New York.

Thursday, March 31, 2011

The U.S. Court of Appeals for the 11th Circuit recently ruled that Congress does not have the authority to subject states to liability for copyright infringement. In this ruling, National Association of Boards of Pharmacy v. Board of...

Tuesday, March 22, 2011

On February 23, the Federal Circuit issued a decision in Centocor Ortho Biotech, Inc. v. Abbott Laboratories, reversing a district court ruling on invalidity and thereby discarding a $1.67 billion damages award.